{
    "info": {
        "nct_id": "NCT03399773",
        "official_title": "Pilot Study: Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells (Dilanubicel) in the Setting of Single Cord Blood Transplantation for Patients With Hematologic Malignancies",
        "inclusion_criteria": "* Patients 10 to 65 years old with a hematologic malignancy in need of hematopoietic cell transplant who are > 30 kg and without a suitable related donor\n* Patient must have hematologic malignancy that meets institutional eligibility requirements for cord blood transplant\n* Malignancies included are:\n\n  * Acute leukemia, including acute myeloid leukemia (AML), biphenotypic acute leukemia or mixed-lineage leukemia, acute lymphoblastic leukemia (ALL); all patients must be in complete response (CR) as defined by < 5% blasts by morphology/flow cytometry in a representative bone marrow sample with adequate cellularity to assess remission status\n  * Myelodysplasia (MDS) International Prognostic Scoring System (IPSS) intermediate (Int)-2 or high risk (i.e., refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEBt]) or refractory anemia with severe pancytopenia or high risk cytogenetics; blasts must be < 10% in a representative bone marrow aspirate\n  * Chronic myeloid leukemia excluding refractory blast crisis; to be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy\n* High dose TBI regimen: 10 to =< 45 years\n* Intermediate intensity regimen: 10 to =< 65 years\n* Patients 10 to =< 45 years: Lansky (< 16 years old) or Karnofsky (>= 16 years old) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1\n* Patients > 45 to =< 65 years: Karnofsky >= 70 or ECOG 0-1 and non-age adjusted comorbidity index =< 5\n* Adults: Calculated creatinine clearance must be > 60 mL and serum creatinine =< 2 mg/dL\n* Children (< 18 years old): Calculated creatinine clearance must be > 60 mL/min\n* Total serum bilirubin must be < 3 mg/dL unless the elevation is thought to be due to Gilbert's disease or hemolysis\n* Transaminases must be < 3 x the upper limit of normal per reference values of treating institution\n* Carbon monoxide diffusing capability (DLCO) corrected >= 60% normal (may not be on supplemental oxygen)\n* For pediatric patients unable to perform pulmonary function tests, O2 saturation > 92% on room air\n* Left ventricular ejection fraction >= 50% OR\n* Shortening fraction > 26%\n* Ability of participant or legally authorized representative to understand and the willingness to sign a written informed consent form\n* DONOR: Minimum requirement: The cord blood (CB) unit must be matched at a minimum at 4/6 HLA-A, B antigens and DRB1 allele with the recipient; therefore, 0-2 mismatches at the A or B or DRB1 loci based on intermediate resolution at HLA-A, B and high resolution allele level typing at HLA- DRB1 are allowed\n* DONOR: Institutional guidelines for HLA-match may be followed as long as the minimum criteria for HLA-matching as above are met\n* DONOR: The CB unit selected for transplant must have a MINIMUM of 2.5 x 10^7 TNC/kg\n* DONOR: The minimum recommended CD34/kg cell dose is 1.7 x 10^5 CD34/kg\n* DONOR: A backup unit must be identified and reserved prior to the start of the treatment plan for possible infusion in the unlikely event of poor post-thaw viability of the primary CB unit. A suitable back up unit will be considered, as follows:\n\n  * Must be matched at a minimum at 4/6 HLA-A, B, DRBl loci with the recipient. Therefore 0-2 mismatches at the A or B or DRBl loci based on intermediate resolution A, B antigen and DRBl allele typing for determination of HLA-match is allowed (Fred Hutch Protocol 2010).\n  * Must contain a MINIMUM of 1.5 x 10^7 TNC/kg to ensure the same requirement we use for a standard double CBT per CB selection guideline (Fred Hutch Protocol 2010).\nHealthy volunteers allowed\nMust have minimum age of 10 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "* Uncontrolled viral or bacterial infection at the time of study enrollment\n* Active or recent (prior 6 month) invasive fungal infection unless cleared by infectious disease (ID) consult\n* History of human immunodeficiency virus (HIV) infection\n* Pregnant or breastfeeding\n* Prior allogeneic transplant\n* Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy; diagnostic lumbar puncture is to be performed\n* < 30 kg",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients 10 to 65 years old with a hematologic malignancy in need of hematopoietic cell transplant who are > 30 kg and without a suitable related donor",
            "criterions": [
                {
                    "exact_snippets": "10 to 65 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hematologic malignancy",
                    "criterion": "hematologic malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in need of hematopoietic cell transplant",
                    "criterion": "need for hematopoietic cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "> 30 kg",
                    "criterion": "weight",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "kg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without a suitable related donor",
                    "criterion": "suitable related donor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have hematologic malignancy that meets institutional eligibility requirements for cord blood transplant",
            "criterions": [
                {
                    "exact_snippets": "hematologic malignancy",
                    "criterion": "hematologic malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "meets institutional eligibility requirements for cord blood transplant",
                    "criterion": "institutional eligibility requirements for cord blood transplant",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Malignancies included are:",
            "criterions": [
                {
                    "exact_snippets": "Malignancies included are:",
                    "criterion": "malignancies",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute leukemia, including acute myeloid leukemia (AML), biphenotypic acute leukemia or mixed-lineage leukemia, acute lymphoblastic leukemia (ALL); all patients must be in complete response (CR) as defined by < 5% blasts by morphology/flow cytometry in a representative bone marrow sample with adequate cellularity to assess remission status",
            "criterions": [
                {
                    "exact_snippets": "Acute leukemia, including acute myeloid leukemia (AML), biphenotypic acute leukemia or mixed-lineage leukemia, acute lymphoblastic leukemia (ALL)",
                    "criterion": "acute leukemia type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "acute myeloid leukemia (AML)",
                                "biphenotypic acute leukemia",
                                "mixed-lineage leukemia",
                                "acute lymphoblastic leukemia (ALL)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "all patients must be in complete response (CR)",
                    "criterion": "complete response (CR)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "complete response (CR)"
                        }
                    ]
                },
                {
                    "exact_snippets": "< 5% blasts by morphology/flow cytometry in a representative bone marrow sample",
                    "criterion": "blasts percentage in bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate cellularity to assess remission status",
                    "criterion": "bone marrow cellularity",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myelodysplasia (MDS) International Prognostic Scoring System (IPSS) intermediate (Int)-2 or high risk (i.e., refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEBt]) or refractory anemia with severe pancytopenia or high risk cytogenetics; blasts must be < 10% in a representative bone marrow aspirate",
            "criterions": [
                {
                    "exact_snippets": "Myelodysplasia (MDS) International Prognostic Scoring System (IPSS) intermediate (Int)-2 or high risk",
                    "criterion": "MDS IPSS risk level",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": [
                                "intermediate (Int)-2",
                                "high risk"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEBt]",
                    "criterion": "refractory anemia type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "refractory anemia with excess blasts (RAEB)",
                                "refractory anemia with excess blasts in transformation (RAEBt)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory anemia with severe pancytopenia",
                    "criterion": "refractory anemia with severe pancytopenia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "high risk cytogenetics",
                    "criterion": "cytogenetics risk level",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "high risk"
                        }
                    ]
                },
                {
                    "exact_snippets": "blasts must be < 10% in a representative bone marrow aspirate",
                    "criterion": "blasts percentage in bone marrow aspirate",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic myeloid leukemia excluding refractory blast crisis; to be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy",
            "criterions": [
                {
                    "exact_snippets": "Chronic myeloid leukemia",
                    "criterion": "chronic myeloid leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding refractory blast crisis",
                    "criterion": "refractory blast crisis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "first chronic phase (CP1)",
                    "criterion": "chronic phase",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "first (CP1)"
                        }
                    ]
                },
                {
                    "exact_snippets": "failed or be intolerant to tyrosine kinase inhibitor therapy",
                    "criterion": "tyrosine kinase inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "failed",
                                "intolerant"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High dose TBI regimen: 10 to =< 45 years",
            "criterions": [
                {
                    "exact_snippets": "10 to =< 45 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 45,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Intermediate intensity regimen: 10 to =< 65 years",
            "criterions": [
                {
                    "exact_snippets": "10 to =< 65 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients 10 to =< 45 years: Lansky (< 16 years old) or Karnofsky (>= 16 years old) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1",
            "criterions": [
                {
                    "exact_snippets": "Patients 10 to =< 45 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 45,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Lansky (< 16 years old) ... >= 70",
                    "criterion": "Lansky score",
                    "requirements": [
                        {
                            "requirement_type": "age applicability",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 16,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "score"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky (>= 16 years old) >= 70",
                    "criterion": "Karnofsky score",
                    "requirements": [
                        {
                            "requirement_type": "age applicability",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 16,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "score"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "status"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "status"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients > 45 to =< 65 years: Karnofsky >= 70 or ECOG 0-1 and non-age adjusted comorbidity index =< 5",
            "criterions": [
                {
                    "exact_snippets": "Patients > 45 to =< 65 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 45,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky >= 70",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "non-age adjusted comorbidity index =< 5",
                    "criterion": "non-age adjusted comorbidity index",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adults: Calculated creatinine clearance must be > 60 mL and serum creatinine =< 2 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Adults: Calculated creatinine clearance must be > 60 mL",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "calculation",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine =< 2 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Children (< 18 years old): Calculated creatinine clearance must be > 60 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Children (< 18 years old)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Calculated creatinine clearance must be > 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "calculation",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total serum bilirubin must be < 3 mg/dL unless the elevation is thought to be due to Gilbert's disease or hemolysis",
            "criterions": [
                {
                    "exact_snippets": "Total serum bilirubin must be < 3 mg/dL",
                    "criterion": "total serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the elevation is thought to be due to Gilbert's disease",
                    "criterion": "Gilbert's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the elevation is thought to be due to ... hemolysis",
                    "criterion": "hemolysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Transaminases must be < 3 x the upper limit of normal per reference values of treating institution",
            "criterions": [
                {
                    "exact_snippets": "Transaminases must be < 3 x the upper limit of normal",
                    "criterion": "transaminases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "x the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Carbon monoxide diffusing capability (DLCO) corrected >= 60% normal (may not be on supplemental oxygen)",
            "criterions": [
                {
                    "exact_snippets": "Carbon monoxide diffusing capability (DLCO) corrected >= 60% normal",
                    "criterion": "carbon monoxide diffusing capability (DLCO)",
                    "requirements": [
                        {
                            "requirement_type": "corrected value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "% normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "may not be on supplemental oxygen",
                    "criterion": "supplemental oxygen",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For pediatric patients unable to perform pulmonary function tests, O2 saturation > 92% on room air",
            "criterions": [
                {
                    "exact_snippets": "pediatric patients",
                    "criterion": "age group",
                    "requirements": [
                        {
                            "requirement_type": "expected age group",
                            "expected_value": "pediatric"
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to perform pulmonary function tests",
                    "criterion": "ability to perform pulmonary function tests",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "O2 saturation > 92% on room air",
                    "criterion": "O2 saturation",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 92,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Left ventricular ejection fraction >= 50% OR",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction >= 50%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Shortening fraction > 26%",
            "criterions": [
                {
                    "exact_snippets": "Shortening fraction > 26%",
                    "criterion": "shortening fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 26,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability of participant or legally authorized representative to understand and the willingness to sign a written informed consent form",
            "criterions": [
                {
                    "exact_snippets": "Ability of participant or legally authorized representative to understand",
                    "criterion": "understanding",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent form",
                    "criterion": "willingness to sign consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DONOR: Minimum requirement: The cord blood (CB) unit must be matched at a minimum at 4/6 HLA-A, B antigens and DRB1 allele with the recipient; therefore, 0-2 mismatches at the A or B or DRB1 loci based on intermediate resolution at HLA-A, B and high resolution allele level typing at HLA- DRB1 are allowed",
            "criterions": [
                {
                    "exact_snippets": "The cord blood (CB) unit must be matched at a minimum at 4/6 HLA-A, B antigens and DRB1 allele with the recipient",
                    "criterion": "HLA match",
                    "requirements": [
                        {
                            "requirement_type": "match level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "out of 6"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "0-2 mismatches at the A or B or DRB1 loci based on intermediate resolution at HLA-A, B and high resolution allele level typing at HLA- DRB1 are allowed",
                    "criterion": "HLA mismatches",
                    "requirements": [
                        {
                            "requirement_type": "allowed mismatches",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "mismatches"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "mismatches"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DONOR: Institutional guidelines for HLA-match may be followed as long as the minimum criteria for HLA-matching as above are met",
            "criterions": [
                {
                    "exact_snippets": "Institutional guidelines for HLA-match may be followed ... minimum criteria for HLA-matching as above are met",
                    "criterion": "HLA-matching",
                    "requirements": [
                        {
                            "requirement_type": "guideline adherence",
                            "expected_value": "Institutional guidelines"
                        },
                        {
                            "requirement_type": "minimum criteria",
                            "expected_value": "as above"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DONOR: The CB unit selected for transplant must have a MINIMUM of 2.5 x 10^7 TNC/kg",
            "criterions": [
                {
                    "exact_snippets": "CB unit selected for transplant must have a MINIMUM of 2.5 x 10^7 TNC/kg",
                    "criterion": "CB unit TNC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25000000.0,
                                "unit": "TNC/kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DONOR: The minimum recommended CD34/kg cell dose is 1.7 x 10^5 CD34/kg",
            "criterions": [
                {
                    "exact_snippets": "minimum recommended CD34/kg cell dose is 1.7 x 10^5 CD34/kg",
                    "criterion": "CD34/kg cell dose",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 170000.0,
                                "unit": "CD34/kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DONOR: A backup unit must be identified and reserved prior to the start of the treatment plan for possible infusion in the unlikely event of poor post-thaw viability of the primary CB unit. A suitable back up unit will be considered, as follows:",
            "criterions": [
                {
                    "exact_snippets": "A backup unit must be identified and reserved",
                    "criterion": "backup unit",
                    "requirements": [
                        {
                            "requirement_type": "identification",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "reservation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "poor post-thaw viability of the primary CB unit",
                    "criterion": "post-thaw viability of the primary CB unit",
                    "requirements": [
                        {
                            "requirement_type": "viability",
                            "expected_value": "poor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must be matched at a minimum at 4/6 HLA-A, B, DRBl loci with the recipient. Therefore 0-2 mismatches at the A or B or DRBl loci based on intermediate resolution A, B antigen and DRBl allele typing for determination of HLA-match is allowed (Fred Hutch Protocol 2010).",
            "criterions": [
                {
                    "exact_snippets": "Must be matched at a minimum at 4/6 HLA-A, B, DRBl loci",
                    "criterion": "HLA match",
                    "requirements": [
                        {
                            "requirement_type": "match level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "loci"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "0-2 mismatches at the A or B or DRBl loci",
                    "criterion": "HLA mismatch",
                    "requirements": [
                        {
                            "requirement_type": "mismatch level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "mismatches"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "mismatches"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must contain a MINIMUM of 1.5 x 10^7 TNC/kg to ensure the same requirement we use for a standard double CBT per CB selection guideline (Fred Hutch Protocol 2010).",
            "criterions": [
                {
                    "exact_snippets": "Must contain a MINIMUM of 1.5 x 10^7 TNC/kg",
                    "criterion": "TNC (Total Nucleated Cells) count",
                    "requirements": [
                        {
                            "requirement_type": "minimum quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15000000.0,
                                "unit": "TNC/kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 10 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 10 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Uncontrolled viral or bacterial infection at the time of study enrollment",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled viral or bacterial infection",
                    "criterion": "viral or bacterial infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active or recent (prior 6 month) invasive fungal infection unless cleared by infectious disease (ID) consult",
            "criterions": [
                {
                    "exact_snippets": "Active or recent (prior 6 month) invasive fungal infection",
                    "criterion": "invasive fungal infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless cleared by infectious disease (ID) consult",
                    "criterion": "clearance by infectious disease consult",
                    "requirements": [
                        {
                            "requirement_type": "clearance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of human immunodeficiency virus (HIV) infection",
            "criterions": [
                {
                    "exact_snippets": "History of human immunodeficiency virus (HIV) infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior allogeneic transplant",
            "criterions": [
                {
                    "exact_snippets": "Prior allogeneic transplant",
                    "criterion": "allogeneic transplant",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy; diagnostic lumbar puncture is to be performed",
            "criterions": [
                {
                    "exact_snippets": "Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy",
                    "criterion": "CNS leukemic involvement",
                    "requirements": [
                        {
                            "requirement_type": "response to treatment",
                            "expected_value": "not clearing with intrathecal chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnostic lumbar puncture is to be performed",
                    "criterion": "diagnostic lumbar puncture",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": "to be performed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* < 30 kg",
            "criterions": [
                {
                    "exact_snippets": "< 30 kg",
                    "criterion": "weight",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "kg"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}